Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:15 PM
Ignite Modification Date:
2025-12-24 @ 1:15 PM
NCT ID:
NCT04918095
Eligibility Criteria:
Inclusion Criteria:
Patients who meet all of the following criteria are eligible for enrollment as study participants:
* Males and females over the age of 40 years.
* physician-diagnosed COPD classified as GOLD 2-3, C-D for at least 1 year.
* Using rescue medications at home delivered by a metered-dose inhaler or MDI.
* Speak, read, and understand English.
* Able to understand study requirements and comply with study procedures.
* Ability to operate a smartphone or tablet (for questionnaire and symptoms input).
Exclusion Criteria:
Subjects who meet any of these criteria are not eligible for enrollment as study participants:
* Physically disabled such that they are incapable of performing forced oscillometry test (for airway impedance measurement)
* Physically disabled such that they are incapable of using metered-dose inhalers.
* Suffer from any visual, hearing, or cognitive impairment that cannot be corrected enough to operate the CareCOPD devices properly. Mild/moderate vision loss and mild hearing loss may be included with appropriate corrective measures that do not affect the device usage.
* Suffering from serious uncontrolled medical conditions that may interfere with study conduct.
* Continuous home Oxygen use for greater than 16 hours/day.
* Inability or unwillingness of the participant to give written informed consent.
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
100 Years
Study:
NCT04918095
Study Brief:
Protocol Section:
NCT04918095